Evaluating B007 for treating generalized myasthenia gravis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to assess the efficacy and safety of B007 in patients diagnosed with generalized myasthenia gravis. Participants will be randomly assigned to receive either B007 or a placebo, with the goal of determining how well B007 improves symptoms associated with this condition. The study will include individuals who have tested positive for specific antibodies related to myasthenia gravis and have a certain level of disease severity. The trial will be conducted across multiple locations to gather diverse data on the treatment's effectiveness.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Sign informed consent form;
2. Subjects with generalized myasthenia gravis;
3. Serum AchR(Acetylcholine receptor)-Ab or MUSK-Ab was positive during screening;
4. MG-ADL ≥5 at screening and baseline;
5. Before randomization, subjects received at least one gMG stable dose of SoC, and maintain a stable dose throughout the test;
6. Subjects agree to use effective contraceptive methods for contraception from signing the informed consent form to 1 year after the last dose. Female subjects considered fertile by the investigator must have negative serum pregnancy tests before the first dose.

Exclusion Criteria:

1. Subjects with MGFA I and V type;
2. Subjects usingprescribed drugs;
3. Subjects with a prescribed disease or history of disease;
4. The subjects has prescribed examination abnormalities that are assessed as unsuitable for participation in the study by the investigator;
5. Known history of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of B007;
6. Subjects who received live vaccine at the specified time before the first dose and are expected to receive the vaccine at the specified time after the last dose;
7. Subjects who have received major surgery or participated in other clinical trials within the prescribed time before screening;
8. Pregnant and lactating women;
9. Fertile female subjects do not agree to use effective contraception from signing the informed consent form to 1 years after the last dose.
10. Sexually active male subjects who do not intend to use an effective contraceptive method during the trial period or within1 years after the last dose, or male subjects who plan to donate sperm during the trial or within 1 year after the last dose;
11. A history of alcohol or drug abuse within the past 12 months;
12. Other conditions deemed unsuitable for participation in this study by the researchers.

Where it's running

• Peking University First Hospital
  Beijing, China Recruiting
• The First Bethune Hospital of Jilin University
  Changchun, China Recruiting
• Xiangya Hospital Central South University
  Changsha, China Recruiting
• Sichuan Provincial People's Hospital
  Chengdu, China Recruiting
• Nanfang Hospital, Southern Medical University
  Guangzhou, China Recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, China Recruiting

Study contacts

• Study coordinator: Jianying Xi
• Email: hsyybwc@163.com
• Phone: 0086-021-52888045

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

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• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.